Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen (CheckMate 169)

November 25, 2020 updated by: Bristol-Myers Squibb

Expanded Access Program With Nivolumab Monotherapy in Subjects With Advanced or Metastatic Squamous (Sq) or Non-Squamous (Non-Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC

The purpose of this study is to provide treatment with nivolumab, a fully human monoclonal antibody, to subjects who have relapsed after treatment with a minimum of 1 prior systemic treatment for advanced or metastatic squamous (Sq) or non-squamous (non-Sq) non-small cell lung cancer (NSCLC) , Stage IIIB/IV and whose physicians believe that nivolumab treatment is appropriate.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 22793
        • Local Institution
      • Rio de Janeiro, Brazil
        • Local Institution
      • Salvador, Brazil, 40170
        • Local Institution
      • São Paulo, Brazil, 01308
        • Local Institution
      • São Paulo, Brazil, 01321
        • Local Institution
      • São Paulo, Brazil, 01406
        • Local Institution
      • São Paulo, Brazil, 01525
        • Local Institution
      • São Paulo, Brazil, 03102
        • Local Institution
      • São Paulo, Brazil, 04538
        • Local Institution
      • São Paulo, Brazil, 05651
        • Local Institution
    • Ceará
      • Fortaleza, Ceará, Brazil, 60130
        • Local Institution
      • Fortaleza, Ceará, Brazil, 60336
        • Local Institution
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41950
        • Local Institution
    • Federal District
      • Brasília, Federal District, Brazil, 70200
        • Local Institution
      • Distrito Federal, Federal District, Brazil, 72025
        • Local Institution
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30430
        • Local Institution
    • Paraná
      • Cascavel, Paraná, Brazil, 85806
        • Local Institution
      • Curitiba, Paraná, Brazil, 80530
        • Local Institution
      • Curitiba, Paraná, Brazil
        • Local Institution
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070
        • Local Institution
      • Recife, Pernambuco, Brazil, 52010
        • Local Institution
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062
        • Local Institution
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil
        • Local Institution
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010
        • Local Institution
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Local Institution
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020
        • Local Institution
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035
        • Local Institution
      • Porto Alegre, Rio Grande do Sul, Brazil, 90470
        • Local Institution
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88034
        • Local Institution
      • Itajaí, Santa Catarina, Brazil, 88301
        • Local Institution
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784
        • Local Institution
      • Campinas, São Paulo, Brazil, 13092
        • Local Institution
      • Jaú, São Paulo, Brazil, 17210
        • Local Institution
      • Ribeirão Preto, São Paulo, Brazil, 14025
        • Local Institution
      • Santo André, São Paulo, Brazil, 09060
        • Local Institution
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 2X6
        • Local Institution
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Local Institution
      • Richmond, British Columbia, Canada, V6X 1A2
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Local Institution
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 2Z3
        • Local Institution
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Local Institution
      • Hamilton, Ontario, Canada
        • Local Institution
      • Oshawa, Ontario, Canada, L1G 2B9
        • Local Institution
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Local Institution
      • Toronto, Ontario, Canada, M4N 3M5
        • Local Institution
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 2A4
        • Local Institution
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Local Institution
      • Montreal, Quebec, Canada, H3A 1A1
        • Local Institution
      • Rimouski, Quebec, Canada, G5L 5T1
        • Centre De Sante Et De Services Sociaux Rimouski Neigette

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Sq or Non-Sq NSCLC, Stage IIIb/IV (histologically or cytologically confirmed)
  • Relapsed after 1 prior platinum-based systemic treatment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status < 2
  • CNS metastasis must be treated and returned to baseline at least 2 weeks before first dose of nivolumab and off steroids or using stable or decreasing dose of < 10 mg prednisone or equivalent
  • Prior chemotherapy, Tyrosine Kinase Inhibitor (TKI) therapy or Immunotherapy (tumor vaccine, cytokine or growth factor to control cancer) must be completed at least 2 weeks before first nivolumab dose

Exclusion Criteria:

  • CNS metastases (untreated and/or symptomatic)
  • Carcinomatous meningitis
  • ECOG Performance status > 3
  • Corticosteroids > 10 mg prednisolone/day (or equivalent)
  • Prior treatment with anti-PD-1, anti-PD-L-1, anti-PDL2, anti-CT137 or anti-CTLA antibody, including ipilimumab or any other drugs specifically targeting T cell costimulation or checkpoint pathways

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimated)

June 18, 2015

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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